FdaApplication
ANDA 203614
Identifiers
- fda_app_no: ANDA203614
Properties
| Property | Value |
|---|---|
| applicant_name | IMPAX LABORATORIES INC |
| application_type | ANDA |
| approval_date | 2017-07-05 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 35MG | CAPSULE, EXTENDED RELEASE;ORAL |
2 products